The Effect of Music on Anxiety and Vasospasm in Patients Undergoing Transradial Angiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
Cardiovascular diseases are among the most significant health issues threatening human well-being, representing the leading cause of mortality and morbidity worldwide and in our country among non-communicable diseases. In Turkey, 33.4% of deaths are attributed to circulatory system diseases and ischemic heart diseases, with coronary artery disease (CAD) being the most common cause. The most frequently applied and accurate invasive diagnostic method for diagnosing CAD is coronary angiography.
Coronary angiography, still regarded as the gold standard today, is a diagnostic procedure that visualizes the heart's blood vessels using contrast media. This procedure can be performed via the femoral, brachial, radial, or axillary arteries. In the past, coronary interventional procedures were commonly performed through the femoral artery. However, following the 2017 European Society of Cardiology (ESC) guidelines on ST-segment elevation myocardial infarction (STEMI) management, the radial artery has become the preferred route due to its lower risk of bleeding and shorter hospital stays. Coronary angiography is performed in a sterile environment while the patient is awake.
Due to its invasive nature and the involvement of a vital organ, coronary angiography can evoke anxiety and fear of death in patients. Factors contributing to this include uncertainty about the procedure, unfamiliarity with the environment, communication with unknown personnel, exposure to medical terminology, and unusual sounds in the procedure room.
The radial artery is more prone to vasospasm than other vessels used in coronary angiography, due to its smaller diameter and rich smooth muscle content. Local anesthesia is administered at the access site to reduce pain during radial artery interventions. Additionally, anticoagulant and vasodilatory drugs are used to prevent procedure-related vasospasms and thrombotic events. Despite these preventive measures, vasospasm is observed in 4-20% of patients undergoing transradial coronary angiography.
Anxiety experienced by patients during the procedure can also contribute to vasospasm in the radial artery. Various invasive and non-invasive interventions, such as listening to music, acupressure, and massage, are frequently employed to reduce patient anxiety. Among these non-invasive methods, providing music during the procedure has gained prominence. Music helps divert patients' attention, enabling them to distance themselves from pain, fear, stress, and anxiety.
详细描述
Type of Study This study is designed as a prospective, two-arm (1:1), randomized controlled clinical trial. The randomized controlled trial will be reported in accordance with the CONSORT guidelines.
Study Setting and Characteristics The study will be conducted in the Coronary Angiography Unit of Mersin University Faculty of Medicine Hospital's Cardiology Clinic. The Coronary Angiography Unit is equipped with eight day-patient beds and two angiography devices. Eight nurses work in this unit between 08:00 and 16:00. Patients scheduled for coronary angiography are admitted to the hospital on the morning of the procedure.
Patients visit the Cardiology outpatient clinic to schedule their coronary angiography, and preparations are carried out in the Coronary Angiography Unit upon their arrival on the day of the procedure. These preparations include obtaining the patient's medical history and informed consent, establishing venous access, measuring vital signs, and performing an electrocardiogram (ECG), which is added to the patient's file. Before the procedure, oral intake is restricted for 4 hours. After the procedure, the arterial sheath in the wrist is removed by the physician immediately after the patient is transferred to their bed. Hemostasis is achieved, and the wrist is covered with a pressure bandage.
If no percutaneous coronary intervention is performed, bleeding control is assessed 6 hours post-procedure, and the patient is discharged. If a percutaneous coronary intervention is performed, the patient is monitored in the cardiology clinic for one day post-procedure.
Randomization and Blinding A total of 90 patients, meeting the inclusion criteria, will be randomized into two groups (A and B) using a computer-generated randomization table prepared by a statistician. The designation of group A or B as the intervention or control group will be determined by a coin toss at the beginning of the study. Information regarding patient group assignments, based on the randomization table, will be placed in opaque envelopes and securely stored by the advisor. Upon initiating the procedure, the investigator will open the envelope after obtaining the patient's informed consent to determine the group assignment. The investigator will be blinded to group assignments, but patients and the investigator cannot be blinded due to the nature of the intervention (music listening). Data will be recorded in a blinded manner, and analysis will be performed by an independent statistician who is unaware of group assignments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Indication for radial coronary angiography (CA) due to non-acute coronary syndrome (ACS) reasons
- •Undergoing coronary angiography for the first time
- •Aged 18 years or older
- •Conscious, oriented, and cooperative
- •Able to read and understand Turkish
- •Willing to participate in the study
- •Without any physical limitations preventing music listening
- •Without a diagnosis of hearing loss
- •Not using a hearing aid
- •Without a diagnosis of anxiety disorder
- •Without any mental health disorders
- •Having signed the "Voluntary Informed Consent Form.
排除标准
- •Indication for radial coronary angiography (CA) due to acute coronary syndrome (ACS)
- •Previous history of coronary angiography
- •Under the age of 18,
- •Unconscious, disoriented, or uncooperative,
- •Unable to read or understand Turkish,
- •Unwilling to participate in the study,
- •Having physical limitations that prevent listening to music,
- •Diagnosed with hearing loss,
- •Using a hearing aid,
- •Diagnosed with an anxiety disorder or taking medication for anxiety,
- •Having a mental health disorder,
- •Not signing the "Voluntary Informed Consent Form."
研究组 & 干预措施
intervention group
In addition to standard care, patients in the intervention group will listen to music through headphones at a volume adjusted to their preference. The selected music will feature Classical Turkish Music performed on the ney in the Hüseyni maqam, which has been shown in previous studies to promote relaxation.
干预措施: Music intervention (Device)
control group
Patients in the control group will receive standard care, including obtaining informed consent, recording medical history, establishing venous access, measuring vital signs, and performing an ECG. After the procedure, the wrist sheath will be removed, bleeding control will be performed, and the wrist will be dressed with a pressure bandage. Patients without percutaneous coronary intervention will be discharged 6 hours post-procedure, while those with percutaneous coronary intervention will remain under observation for one day.
结局指标
主要结局
the State-Trait Anxiety Inventory (STAI)
时间窗: day 1
The STAI (State-Trait Anxiety Inventory) is a psychological tool developed to assess individuals' anxiety levels and consists of a total of 40 questions. The scale addresses anxiety in two distinct dimensions: State Anxiety and Trait Anxiety. State anxiety measures the individual's temporary level of anxiety in response to a specific and transient situation, while trait anxiety evaluates the individual's general tendency to experience anxiety and their predisposition to perceive anxiety as a personality trait. Both subscales consist of 20 questions, and individuals are asked to indicate how much the given statements apply to them.
次要结局
未报告次要终点
研究者
Nida Aykuş Yeşil
Graduate Nursing Student
Mersin University